HealthyPhase 1NCT00791388

Multiple Rising Oral Dose Study of PG 760564 Administered Twice Daily to Healthy Male/Female Volunteers for 14 Days

A Phase 1 study testing PG-760564 in people with Healthy, run by Procter and Gamble at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses). Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: PG-760564
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteUnited States
Study dates: Aug 2005to Jan 2006
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males and surgically sterile or post-menopausal (last menstrual period > 1 year at the time of enrollment) healthy females, 18-45 years of age, inclusive, at screening;
Who have not used tobacco or nicotine-containing products within the past 3 months;
Willing to abstain from caffeine or xanthine-containing beverages, including coffee and tea, chocolate, alcohol, grapefruit juice, and Seville oranges, from 24 hours before admission and for the duration of the study;
Who have a body mass index (BMI) between 18 and 32 kg/m2.

Who cannot join

History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;
History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding;
History of autoimmune disease;
History of immunodeficiency or of unusual susceptibility to infectious diseases;
History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV);
Any history of hypersensitivity or clinically significant allergy to any drug;

Show all 9Show fewer

Personal or family history of prolonged QT syndrome or any cardiac conduction abnormality;
Family history of sudden death;
History of uveitis or inflammatory ocular disease

Trial locations and contacts

1 site in 1 country.

United States1 site

Stuart I Harris, MD, PhD
Miami, Florida, 33126

Other trials in United States

About this study

Official title: Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).

Read the detailed description

Conditions: Healthy
Being tested: Placebo, PG-760564
Keywords: Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
oral capsule, 2x/day for 14 days
PG-760564Drug
oral capsule, 50 mg, 2x/day for 14 days
PG-760564Drug
oral capsule, 100mg, 2x/day for 14 days
PG-760564Drug
oral capsule, 200 mg, 2x/day for 14 days
PG-760564Drug
oral capsule, 400 mg, 2x/day for 14 days

Study groups in NCT00791388
Study group	Role	What they receive
placebo	Placebo comparator	placebo capsule Receives: Drug: Placebo
50 mg PG 760564	Experimental	50 mg PG 760564 active Receives: Drug: PG-760564
100 mg PG 760564	Experimental	100 mg PG 760564 active Receives: Drug: PG-760564
200 mg PG 760564	Experimental	200 mg PG 760564 active Receives: Drug: PG-760564
400 mg PG 760564	Experimental	400 mg PG 760564 active Receives: Drug: PG-760564

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14
the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours
Measured: 14 days
Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14
Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14
Measured: 12 hours on Day 14
Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14
the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14
Measured: 12 Hours on Day 14
t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14
t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14
Measured: over a Dosing Interval (τ = 12 Hours) on Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2005Jan 2006

First posted14 Nov 2008 (estimated)
Study startAug 2005
Primary completionJan 2006
Study completionJan 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00791388
Sponsor's protocol ID: 2005046
Status last verified: Sep 2011
First submitted: 13 Nov 2008
Last updated: 4 Nov 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).
ClinicalTrials.gov ID: NCT00791388
Acronym / sponsor ID: 2005046
Conditions: Healthy
Keywords: Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Procter and GambleIndustry (pharma, biotech, devices)
Study start: Aug 2005
Primary completion: Jan 2006 (actual)
Study completion: Jan 2006 (actual)
First posted: 14 Nov 2008 (estimated)
Results: Posted 4 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
placebo	Placebo comparator	Drug: Placeboplacebo capsule
50 mg PG 760564	Experimental	Drug: PG-76056450 mg PG 760564 active
100 mg PG 760564	Experimental	Drug: PG-760564100 mg PG 760564 active
200 mg PG 760564	Experimental	Drug: PG-760564200 mg PG 760564 active
400 mg PG 760564	Experimental	Drug: PG-760564400 mg PG 760564 active

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy males and surgically sterile or post-menopausal (last menstrual period > 1 year at the time of enrollment) healthy females, 18-45 years of age, inclusive, at screening;
Who have not used tobacco or nicotine-containing products within the past 3 months;
Willing to abstain from caffeine or xanthine-containing beverages, including coffee and tea, chocolate, alcohol, grapefruit juice, and Seville oranges, from 24 hours before admission and for the duration of the study;
Who have a body mass index (BMI) between 18 and 32 kg/m2.

Key exclusion criteria (9 listed)

History of diabetes, cardiovascular, hepatic, renal, or malabsorptive disease;
History of peptic ulcer disease, hemorrhoids, GI surgery (appendectomy and cholecystectomy are allowed), or GI bleeding;
History of autoimmune disease;
History of immunodeficiency or of unusual susceptibility to infectious diseases;
History of tuberculosis, acquired immunodeficiency syndrome (AIDS), or infection with human immunodeficiency virus (HIV);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebooral capsule, 2x/day for 14 days	Drug	placebo
PG-760564oral capsule, 50 mg, 2x/day for 14 days	Drug	50 mg PG 760564
PG-760564oral capsule, 100mg, 2x/day for 14 days	Drug	100 mg PG 760564
PG-760564oral capsule, 200 mg, 2x/day for 14 days	Drug	200 mg PG 760564
PG-760564oral capsule, 400 mg, 2x/day for 14 days	Drug	400 mg PG 760564

Primary outcome

AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14
Time frame: 14 days
the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours
Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14
Time frame: 12 hours on Day 14
Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14
Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14
Time frame: 12 Hours on Day 14
the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14
t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14
Time frame: over a Dosing Interval (τ = 12 Hours) on Day 14
t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14

Results and safety

Results posted to the registry on 4 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	3	3
50 mg PG 760564	8	7
100 mg PG 760564	0	0
200 mg PG 760564	0	0
400 mg PG 760564	0	0

Primary outcome: AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14

Time frame: 14 days. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Placebo n = 0	50 mg PG 760564 n = 7	100 mg PG 760564 n = 8	200 mg PG 760564 n = 8	400 mg PG 760564 n = 4
Value	–	12090.998 (2926.950)	23472.1329 (9858.248)	30005.781 (9955.931)	50354.938 (9781.333)

Population analysed: PG 760564 blood plasma concentrations were not measured for the placebo arm

Primary outcome: Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14

Time frame: 12 hours on Day 14. Mean (Standard Deviation). Unit: ng/mL

Measure	Placebo n = 0	50 mg PG 760564 n = 7	100 mg PG 760564 n = 8	200 mg PG 760564 n = 8	400 mg PG 760564 n = 4
Value	–	1601.4 (318.2)	2951.3 (1148.2)	3935.0 (953.1)	7195.0 (279.2)

Primary outcome: Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14

Time frame: 12 Hours on Day 14. Mean (Standard Deviation). Unit: hours

Measure	Placebo n = 0	50 mg PG 760564 n = 7	100 mg PG 760564 n = 8	200 mg PG 760564 n = 8	400 mg PG 760564 n = 4
Value	–	2.46 (0.98)	2.89 (0.63)	3.01 (0.54)	2.03 (0.82)

Primary outcome: t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14

Time frame: over a Dosing Interval (τ = 12 Hours) on Day 14. Mean (Standard Deviation). Unit: hours

Measure	Placebo n = 0	50 mg PG 760564 n = 7	100 mg PG 760564 n = 8	200 mg PG 760564 n = 8	400 mg PG 760564 n = 4
Value	–	9.411 (2.640)	7.882 (1.814)	10.223 (3.947)	9.701 (1.714)

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 13 (0%)	7 of 13 (53.8%)	Not reported
50 mg PG 760564	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
100 mg PG 760564	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
200 mg PG 760564	0 of 8 (0%)	8 of 8 (100%)	Not reported
400 mg PG 760564	0 of 8 (0%)	8 of 8 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William S Aronstein, MD, PhD study director

Procter and Gamble

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PG-760564 in people with Healthy, run by Procter and Gamble at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14 (time frame: 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00791388.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2011.